The clinical investigation is a multi-center, prospective, non-randomized, observational, FDA-required post-approval study designed to further evaluate the safety and effectiveness of the Biocor and Biocor Supra Valves.

Eligibility

Ages Eligible for Study:

18 Years and older (Adult, Senior)

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Requires aortic or mitral valve replacement (heart surgery such as bypass is allowed at the same time)

Legal age

Signed informed consent prior to surgery

Willing to complete all follow-up requirements

Exclusion Criteria:

Pregnant or nursing women

Already have had a valve replaced other than that for the scheduled replacement

Needs another valve replaced

Cannot return for required follow-up visits

Have active endocarditis

Acute preoperative neurological event (such as a stroke)

Renal dialysis

History of substance abuse within one year or is a prison inmate

Participating in another study

Had the Biocor or Biocor Supra valve implanted but then the device was explanted

Life expectancy less than five years

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636987